On September 29, 2016 Medigene AG (MDG1, Frankfurt, Prime Standard), Germany, and bluebird bio, Inc. (Nasdaq: BLUE), USA, reporteded the signing of a strategic research and development collaboration and licensing agreement encompassing T cell receptor (TCR) immunotherapies against four targets (Press release, bluebird bio, SEP 29, 2016, View Source [SID:SID1234515487]). Schedule your 30 min Free 1stOncology Demo! "We are delighted to collaborate with bluebird bio, a leader in the field of cell and gene therapy, including cancer immunotherapy," said Dolores J. Schendel, chief executive officer and chief scientific officer, Medigene. "With its T cell immunotherapy expertise and outstanding gene delivery and genome editing capabilities, bluebird bio is an ideal partner for us to jointly discover and develop a new generation of T cell therapeutics to treat unmet oncology indications."
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"Medigene’s proprietary technology to generate highly active natural TCRs makes them an ideal partner, enabling us to broaden our pipeline with TCR-based product candidates against four new targets and continue to build our leadership in immuno-oncology," said Rick Morgan, Ph.D., vice president of immunotherapy, bluebird bio. "This agreement exploits our core expertise in lentiviral gene transfer, genome editing and synthetic biology, and leverages our manufacturing and clinical development capabilities to build a broad, fully integrated immuno-oncology franchise."
"Our first commercial agreement based on Medigene’s TCR technology is testimony to our rapid progress as an immuno-oncology company," added Dave Lemus, chief operating officer, Medigene. "Furthermore, the agreement provides Medigene with significant additional financial resources for both the short term and potentially the long term as we participate in the value creation of the cell therapeutics that we jointly create."
Under the terms of the agreement, Medigene will be responsible for the generation and delivery of the TCRs using its TCR isolation and characterization platform. Following the collaborative preclinical development, bluebird bio will assume sole responsibility for the clinical development and commercialization of the TCR product candidates and will receive an exclusive license for the intellectual property covering the resulting TCRs.
Medigene will receive an upfront payment of USD 15 million as well as potential preclinical, clinical, regulatory and commercial milestone payments, which together could total over USD 1 billion in the aggregate for the four potential TCR products across several indications. Additionally, Medigene will receive R&D funding for all work performed in the collaboration and is eligible for tiered royalty payments on net sales up to a double-digit percentage.
Contractual parties to the agreement are Medigene Immunotherapies GmbH, a wholly owned affiliate of Medigene AG, and bluebird bio, Inc.
Press and analysts’ conference call: Medigene will hold a press and analysts conference call (in English) today at 3:00 pm CEST / 9:00 am EDT and will webcast the call live via Medigene’s website, www.medigene.com.
About Medigene’s TCR technology: The TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient’s T cells outside the body (ex-vivo).
TCR therapy is developed to detect a greater number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR T) therapy. Medigene is preparing the clinical development of its first TCR candidates and is establishing a library of recombinant T cell receptors, and has established Good Manufacturing Practice (GMP)-compliant processes for their combination with patient-derived T cells. The start of a clinical Phase I TCR investigator-initiated trial (IIT) with Medigene participation is expected in 2017. Medigene plans to commence its own first clinical TCR trial in 2017 and a second trial in 2018.
Medigene’s TCR technology for adoptive T-cell therapy is one of the company’s three highly innovative and complementary immunotherapy platforms in immuno-oncology.